Standards for Accreditation. Updated November 7, 2014

Transcription

1 Standards for Accreditation Updated November 7, 2014

2 The practice of sleep medicine continues to evolve as new research, policy and technology shift the field to comprehensive patient management. Accreditation of entities that offer diagnostic testing and comprehensive management for sleep disorders is increasingly important as care shifts to improving population health and engaging patients while containing cost. The American Academy of Sleep Medicine (AASM) developed Standards for Accreditation with the primary purpose of ensuring that the highest quality of care is delivered to patients with sleep disorders. This evolution, however, necessitates an update to the AASM Standards for Accreditation to reflect the models of clinical practice that have emerged in recent years. As such, the former AASM Standards for Accreditation of Sleep Disorders Centers and the former AASM Standards for Accreditation of Out of Center Sleep Testing for Adult Patients have been combined into one accreditation platform. Variability in practice remains, and the Table of Contents explains the applicability of standards based on the type of practice. igh Quality Patient Care and Management All qualified sleep medicine physicians and providers must be committed to providing quality patient care. Patients benefit greatly from direct personal interaction with the diagnosing/treating sleep physician and other center staff providers. It is therefore the general position of the AASM that, in ideal circumstances, all patients evaluated and treated in an accredited sleep center should be seen by a board certified sleep physician or center staff provider prior to testing and the initiation of treatment. owever, the AASM recognizes that patient consultations may be restricted by some health plans or prevented by a variety of other reasonable and unavoidable circumstances. Every effort should be made to manage these conditions in the best interest of the patient and in a way that promotes high quality care. It is the recommendation of the AASM that a sleep center should include in its policies a description of any circumstances that prevent patient consultations. Clinical Recommendations The AASM uses a rigorous evidence-based process to establish Practice Parameters and Clinical Guidelines on a variety of topics that are relevant to the practice of sleep medicine. Accredited sleep entities must adopt and follow the level recommendation statements in all active AASM Practice Parameter and Clinical Guideline papers. level recommendation statements are in bold print so that they can be identified easily. In addition, it is recommended that accredited entities adopt and follow all other recommendation statements (i.e., Guideline, Option, and Consensus level recommendations) in all active AASM Practice Parameter and Clinical Guideline papers. Clinical Judgment The AASM recognizes that the practice of sleep medicine, like all other medical disciplines, is dynamic, complex and requires clinical judgment. AASM Practice Parameters and Clinical Guidelines are not designed to limit physicians from using their medical judgment. Therefore, unique circumstances may require deviation from AASM clinical recommendation for the appropriate evaluation and management of select patients. owever, in such instances the AASM accredited entity is expected to keep documentation on file that provides justification for the deviation in standard clinical practice. 2

3 Compliance Entities accredited by the AASM must be in compliance with all accreditation standards at the time of application and throughout the accreditation period. If it is determined in the application review process that an entity is not in compliance with the required standards, the application will be returned, and the entity will need to resubmit its application once the required standards are met. or accredited sleep facilities applying for SAT accreditation, the most recent version of applicable standards at the time of application applies. The AASM reserves the right to revoke accreditation for entities that are found to be non-compliant with the Standards for Accreditation during the period of accreditation. Denial Denial of accreditation will be recommended by the site visitor, reviewers, accreditation committee, or staff when one or more of the following conditions are identified: 1. The entity fails to meet any of the accreditation standards that are indicated as MANDATORY. Entities will not be issued provisos for accreditation standards indicated as MANDATORY. (If granted accreditation with provisos, the entity receives a letter that describes certain stipulations that must be met by a specified deadline to retain accreditation.) 2. The entity is determined to be non-compliant with more than ten (10) non-mandatory accreditation standards. 3. The entity fails to resolve provisos within the period of time allotted to correct the provisos. 4. The AASM has evidence that the entity submitted falsified documents or misrepresented information in seeking to achieve or retain accreditation. These conditions for denial apply to sleep facility and SAT accreditation separately. Any standard that applies to both sleep facility and SAT accreditation that is not met is considered as a failed standard for both the sleep facility and SAT accreditations. Disclaimer The AASM is one of multiple bodies that offer accreditation to entities that offer sleep services. Accreditation by the AASM is a voluntary program offered to entities that meet the standards contained in this document. The AASM reserves the right to modify, add or remove accreditation standards at its own discretion without notice. In addition, the AASM reserves the right to interpret the standards for accreditation as deemed appropriate. American Academy of Sleep Medicine 2510 North rontage Road Darien, IL Voice: acsimile: accreditation@aasmnet.org 3

4 Table of Contents of Accreditation Standards The Standards for Accreditation have changed to reflect the current practice of sleep medicine, combining the former AASM Standards for Accreditation of Sleep Disorders Centers and the former AASM Standards for Accreditation of Out of Center Sleep Testing for Adult Patients. As such, terminology has been updated to reflect this change. or the purpose of clarity and brevity, the remainder of this document will use three terms to describe accredited sleep practices. Entity is used generally to refer to both sleep facilities and SAT programs, as defined below. Sleep facility is used specifically to refer to sleep centers that are comprised of both a clinic where patient evaluation and management occurs and laboratory testing that utilizes overnight polysomnography for diagnostic testing of patients. The clinic and laboratory may be housed in separate locations. SAT program (formerly known as OCST) is used specifically to refer to a sleep program where patients are evaluated and managed for sleep disorders, and where diagnostic testing is performed by ome Sleep Apnea Testing (SAT), which is defined as sleep testing performed outside of the sleep facility. SAT may be a clinical service provided by a sleep facility, and/or it may be a service offered by a stand-alone provider of SAT. Please note, the application for accreditation will specify the type of accreditation for which you are applying. Please note that some standards may only apply to a facility or SAT Program because of the nature of the standard. As such, the current Standards for Accreditation have a key that includes three codes (, and ) that define the applicability of the standard. The code is listed next to the standard for reference. Key The specific Standard applies only to entities applying for SAT accreditation. A. General Standards A-1- acility License (MANDATORY) p. 7 A-2- B. Personnel Medical Code of Conduct and Compliance with the ealth Insurance Portability and Accountability Act (IPAA) (MANDATORY) p. 7 B-1- Medical Director (MANDATORY) p. 8 B-2- Medical Director Continued (MANDATORY) p. 8 B-3- Medical Director Continued (MANDATORY) p. 8 B-4- Medical Director Responsibilities(MANDATORY) p. 8 B-5- Medical Director Responsibilities Continued p. 9 B-6- Medical Director Continuing Education (MANDATORY) p. 9 B-7- Board Certified Sleep Specialist (MANDATORY) p. 9 4

5 B-8- Board Certified Sleep Specialist Responsibilities (MANDATORY) p. 10 B-9- Board Certified Sleep Specialist Continuing Education (MANDATORY) p. 10 B-10- Interpreting Physician(s) (MANDATORY) p. 10 B-11- Interpreting Physician(s) Qualifications (MANDATORY) p. 10 B-12- Interpreting Physician(s) Continuing Education p. 11 B-13- Sleep Technicians and Technologists p. 11 B-14- Registered Sleep Technologist p. 11 B-15- Sleep Technician and Technologist Continuing Education p. 12 B-16- Non-registered Sleep Technologist p. 12 B-17- Scoring Personnel p. 12 B-18- Scoring Personnel Continuing Education p. 12 B-19- Center Staff Provider Continuing Education p. 13 B-20- SAT On-Call Coverage p. 13 C. Patient Policies C-1- Patient Acceptance p. 13 C-2- Record Review of Direct Referrals p. 14 C-3- Practice Parameter Requirements p. 14 D. acility and Equipment D-1- Permanent Address p. 14 D-2- Phone Line p. 14 D-3- Signage p. 14 D-4- Stationery p. 14 D-5- Use of Space p. 15 D-6- Testing Bedrooms Physical Characteristics p. 15 D-7- Testing Bedrooms & Emergency Care p. 15 D-8- Bathroom acilities p. 15 D-9- andicap Testing Bedroom and Bathroom p. 15 D-10- Control Room p. 15 D-11- Communication p. 16 D-12- Video Recording p. 16 D-13- Polygraphic Equipment p. 16 D-14- Portable Recording Equipment p. 16 D-15- PAP Therapy p. 16 The specific Standard applies only to entities applying for SAT accreditation. 5

6 E. Policies and Procedures E-1- Policy and Procedures Manual p. 17 E-2- Protocols: PSG, SAT, MSLT, MWT, and PAP Titration p. 17 E-3- Other Protocols p. 17 E-4- Equipment Maintenance p. 17 E-5- acility Equipment Maintenance p. 17 E-6- SAT Equipment Maintenance p. 18. Data Acquisition, Scoring and Reporting -1- Signals and Equipment p PSG Reports p SAT Recording Equipment p SAT Reports and Interpretations p Conducting MSLT and MWT p PSG Scoring p Computer-assisted Scoring p Inter-scorer Reliability p Review of Raw Data p Review of SAT Raw Data p. 20 G. Patient Evaluation and Care G-1- Patient Management (MANDATORY) p. 21 G-2- Patient Management Continued (MANDATORY) p. 21 G-3- Documenting Patient Evaluation/Management p. 21. Patient Records -1- Medical Records p PAP Assessment p Database p. 22 I. Emergency Procedures I-1- Emergency Plan p. 22 I-2- SAT Emergency Procedure p. 23 I-3- Emergency Equipment p. 23 J. Quality Assurance J-1- QA Program p. 23 J-2- Reporting QA Program p. 23 J-3- Quality Improvement p The specific Standard applies only to entities applying for SAT accreditation.

7 A. General Standards A-1 acility License (MANDATORY) Any entity accredited by the AASM must maintain a valid license to provide health care services. If a valid license is not required by applicable law, the entity may submit a certificate of occupancy and/or permit to provide health care services. If none of the above is required by applicable law, the Medical Director must submit a written attestation. It is the responsibility of AASM accredited entities to maintain compliance with all licensing acts, local building codes and any other laws relevant to the entity s operation. ailure to comply with the stipulations in this standard is sufficient justification for denial and/or revocation of accreditation. A-2 Medical Code of Conduct and Compliance with the ealth Insurance Portability and Accountability Act (IPAA) (MANDATORY) All entities accredited by the AASM are required to follow the Code of Medical Ethics of the American Medical Association Council on Ethical and Judicial Affairs Current Opinions, which the AASM adopted as official policy in The sleep entity must either have on hand or have the ability to access easily the Code of Medical Ethics. 1. All entities accredited by the AASM must have or operate under written policies that govern the practices pertaining to maintaining confidentiality of patient health information (PI). Protecting PI must be the responsibility of all personnel employed by the accredited entity, and all employees must attest to their awareness that federal and state privacy laws, along with any additional privacy rules, protect PI. Except as permitted by law, personnel shall not share any PI with any party, including but not limited to other health care providers, health care institutions, DME companies, employers or payers. 2. The Medical Director is responsible for ensuring that all appropriate personnel are trained regarding IPAA regulations, and that patients are informed of their rights under IPAA, including the unauthorized solicitation of PI by any person or company, through distribution of a privacy practices notices. 3. Accredited entities must promptly notify all appropriate parties of any IPAA violations. Accredited entities must have or operate under written privacy breach notification policies and procedures that outline the actions necessary to notify patients when a breach of their unsecured PI has occurred that compromises the security or privacy of such information. B. Personnel Standards B-1 through B-9 relate to the appointment, responsibilities and continuing education of a physician medical director and/or the appointment of a physician or PhD board certified sleep specialist in the case of sleep facility accreditation. A physician meeting all the requirements of B-1 through B-9 can fulfill both designations. A PhD can only fulfill the board certified sleep specialist designation for facility accreditation only. Effective January 1, 2016, the sleep facility medical director must be a board certified sleep physician. The specific Standard applies only to entities applying for SAT accreditation. 7

8 Patient and employee safety and security must be insured to the greatest extent possible. The AASM recommends that accredited entities institute a standard procedure for verifying the employment history, education, criminal record and other background information of all applicants and employees, prior to and during employment. These checks are required for employees who have direct patient contact, unsupervised access to patients or their belongings, or access to PI. Such checks can identify potential candidates who may not be an appropriate employee. B-1 Medical Director (MANDATORY) AASM accredited entities must designate a single medical director who is a physician with a license valid in the state of the entity and in all states in which patients are seen. A copy of each state medical license must be submitted with the application. Exceptions to the requirement for a license valid in each state in which patients are seen are made for physician employees of federal facilities. B-2 Medical Director Continued (MANDATORY) An individual can serve as medical director of up to three (3) sleep facilities, regardless of their accreditation status. If an individual is medical director of more than three facilities, the total number of beds shall not exceed 16 beds. The medical director must be present in the sleep facility on a regular basis and not less than 8 hours each month. B-3 Medical Director Continued (MANDATORY) The designated SAT medical director must be a sleep specialist who meets at least one of the following requirements: 1. A physician who is board certified in sleep medicine by the American Board of Sleep Medicine (ABSM) or an individual certified in sleep medicine by either a member board of the American Board of Medical Specialties (ABMS) or a member board of the American Osteopathic Association (AOA). 2. A physician who has been accepted by an ABMS or AOA approved board to sit for the examination in sleep medicine. To retain the accreditation, the examination in sleep medicine must be passed within 2 examination cycles. To meet this requirement, the individual must provide, in the application packet, a letter of acceptance to sit for the examination by the ABMS or AOA approved board. Upon completion of the examination, the individual must provide a copy of the official notification from the ABMS or AOA board indicating final status. 3. A physician who has completed a 12-month Accreditation Council for Graduate Medical Education (ACGME) accredited fellowship in sleep medicine and is awaiting the first available opportunity to apply to an ABMS board to sit for the sleep medicine examination. To retain accreditation, the ABMS examination in sleep medicine must be passed within 2 examination cycles. B-4 Medical Director Responsibilities (MANDATORY) The medical director: 8 The specific Standard applies only to entities applying for SAT accreditation.

9 1. Is responsible for the direct and ongoing oversight of testing. 2. Is responsible for the qualifications of all medical and technical personnel. B-5 Medical Director Responsibilities Continued The SAT medical director: 1. Is responsible for the ongoing oversight of the testing protocols, the quality of testing and the proper operation and calibration of the equipment. 2. Is responsible for the development of detailed job descriptions for all SAT technical personnel that addresses their specific qualifications, duties and responsibilities, as well as the ongoing training requirements for SAT. 3. Is responsible for the quarterly review, report, and modification as necessary of the SAT program s quality assurance program. 4. Is responsible for ensuring that only appropriately licensed healthcare professionals (MD, DO, APRN or PA) with prescriptive authority in the state where the patient would be tested can request an SAT. B-6 Medical Director Continuing Education (MANDATORY) The medical director must earn at least 10 credits per year averaged over three years of AMA PRA Category 1 CME credit in sleep medicine. Compliance with CME requirements must be documented. or the SAT program medical director, physicians recently completing a sleep medicine fellowship will have the CME requirement waived for 36 months from the end date of the program. B-7 Board Certified Sleep Specialist (MANDATORY) AASM accredited sleep facilities must designate a single professional sleep specialist who meets at least one of the following requirements: 1. An individual who is board certified in sleep medicine by the ABSM or an individual certified in sleep medicine by either a member board of the ABMS or a member board of the AOA. 2. An individual who has been accepted by an ABMS or AOA approved board to sit for the examination in sleep medicine. To retain the accreditation, the examination in sleep medicine must be passed within 2 examination cycles. To meet this requirement, the individual must provide in the application packet a letter of acceptance to sit for the examination by the ABMS or AOA approved board. Upon completion of the examination, the individual must provide a copy of the official notification from the ABMS or AOA board indicating final status. 3. An individual who has completed a 12-month ACGME accredited fellowship in sleep medicine and is awaiting the first available opportunity to apply to an ABMS board to sit for the sleep medicine examination. To retain accreditation, the ABMS examination in sleep medicine must be passed within 2 examination cycles. The specific Standard applies only to entities applying for SAT accreditation. 9

10 B-8 Board Certified Sleep Specialist Responsibilities (MANDATORY) The designated board certified sleep specialist: 1. Must provide direct and ongoing oversight of the testing protocols and the quality of testing including the proper operation and calibration of the equipment. 2. Must review, report, and modify as necessary the facility s quality assurance program on a quarterly basis. 3. Must be on-site in the sleep facility on a regular basis and not less than 8 hours monthly. 4. Can serve as board certified sleep specialist of up to three (3) sleep facilities, regardless of their accreditation status. If an individual is board certified sleep specialist of more than three facilities, the total number of beds shall not exceed 16 beds. B-9 Board Certified Sleep Specialist Continuing Education (MANDATORY) The board certified sleep specialist must earn at least 10 credits per year averaged over 3 years of AMA PRA Category 1 CME (for a physician) or CE (for a PhD) in sleep medicine. Compliance with CME/CE requirements must be documented. If a single individual serves as both the designated medical director and board certified sleep specialist, the individual must meet only the CME requirements of the medical director. B-10 Interpreting Physician(s) (MANDATORY) The SAT interpreting physician(s) must have a valid state license in all states where patients are tested. B-11 Interpreting Physician(s) Qualifications (MANDATORY) The physician(s) responsible for interpretation of SAT data and diagnoses of patients must be a sleep specialist who meets at least one of the following requirements: 1. A physician who is board certified in sleep medicine by the ABSM or an individual certified in sleep medicine by either a member board of the ABMS or a member board of the AOA. 2. A physician who has been accepted by an ABMS or AOA approved board to sit for the examination in sleep medicine. To retain the accreditation, the examination in sleep medicine must be passed within 2 examination cycles. To meet this requirement, the individual must provide in the application packet a letter of acceptance to sit for the examination by the ABMS or AOA approved board. Upon completion of the examination, the individual must provide a copy of the official notification from the ABMS or AOA board indicating final status. 3. A physician who has completed a 12-month ACGME accredited fellowship in sleep medicine and is awaiting the first available opportunity to apply to an ABMS board to sit for the sleep medicine examination. To retain accreditation, the ABMS examination in sleep medicine must be passed within 2 examination cycles. 10 The specific Standard applies only to entities applying for SAT accreditation.

11 B-12 Interpreting Physician(s) Continuing Education All SAT interpreting physicians must participate in at least 10 credits per year averaged over three years of AMA PRA Category 1 Credit in sleep medicine. Compliance with CME requirements must be documented. The AASM has adopted job descriptions that delineate the education, training, and responsibilities of sleep technologists, sleep technicians, and sleep technician trainees. All sleep technologists/technicians must be able to perform the duties listed in the AASM approved job descriptions. Standards B-13 through B-19 address requirements for sleep technologists, technicians and trainees. These standards do not differentiate between the various job descriptions or titles that sleep facilities may use for the employment of sleep technicians and technologists. or example, a sleep technologist or technician whose primary responsibility is to score a sleep study is subject to the same accreditation standards as a sleep technologist or technician whose primary responsibility is sleep test monitoring. Specifically, CPR certification is required for all sleep facility technical staff members, regardless of their duties. If technical staff performs only SAT duties, they do not require CPR. B-13 Sleep Technicians and Technologists 1. AASM accredited sleep facilities must maintain appropriately trained, supervised, and, where required by state law, licensed sleep technologists. Technologist staffing at accredited facilities must be adequate to address the workload of the sleep facility and assure the safety of patients. The AASM recommends a patient to technologist ratio of 2:1 under usual circumstances for attended polysomnography at accredited sleep facilities. Exceptions to the requirement for a license required by state law are made for sleep technologist employees of federal facilities. 2. AASM accredited SAT programs must maintain appropriately trained, supervised, and, where required by law, licensed personnel. It is the responsibility of the medical director to ensure that training is provided to the technical personnel on the proper use of SAT devices including: Device operations, application of sensors, use, maintenance, warnings and safety; Instruction of patients in the use of SAT devices; Troubleshooting of SAT problems; Infection control; and Scoring of data Please refer to the SAT Policy Statement, which includes additional language under the Properly Trained Personnel heading. B-14 Registered Sleep Technologist A minimum of one sleep technologist must be registered in sleep technology or accepted to sit for the registry examination through one of the following organizations: The specific Standard applies only to entities applying for SAT accreditation. 11

12 1. ABSM 2. NBRC 3. BRPT 4. Another organization that offers an equivalent examination accepted by the AASM The individual(s) fulfilling this standard must be present at the facility at least 30 hours per week. If the facility is open fewer than 40 hours per week, then the registered technologist must be present at the facility for 75% of operating hours. Note: An accredited facility that loses its sole registered technologist will have 120 days to fulfill this standard. B-15 Sleep Technician and Technologist Continuing Education All sleep facility s technical staff must each participate in at least 10 hours per year averaged over three years of AMA PRA Category 1 CME or CEC sleep-related educational activities. This must be documented for each technical staff member. Education sessions conducted at the facility are acceptable for fulfilling this standard provided the session has defined educational objective(s) and attendance is documented by a roster signed by the sleep facility s medical director. Each sleep technician and technologist must have valid cardiopulmonary resuscitation (CPR) certification that includes skills training. B-16 Non-registered Sleep Technologist All technologists and technicians conducting (and/or scoring) sleep testing who are not registered by the ABSM, National Board for Respiratory Care (NBRC), Board of Registered Polysomnographic Technologists (BRPT), or other accepted certification body: 1. Must be enrolled in or have completed the A-STEP Online Self Study Modules. Non-registered technologists and technicians must complete A-STEP Online Self Study Modules within two years of enrollment. OR 2. Must be enrolled in or have completed training in polysomnography in a program accredited by the Commission on Accreditation of Allied ealth Education Programs (CAAEP) or a Commission on Accreditation for Respiratory Care (CoARC) program with the polysomnography option. B-17 Scoring Personnel or SAT programs only, scoring personnel include Registered Sleep Technologists (RST), Registered Polysomnographic Technologists (RPSGT), Certified Polysomnographic Technicians (CPSGT), or respiratory therapists with the sleep disorders specialist certification (either CRT-SDS, or RRT-SDS), Sleep Specialists, or other AASM recognized certifications. 12 The specific Standard applies only to entities applying for SAT accreditation.

13 B-18 Scoring Personnel Continuing Education The SAT program s scoring personnel must each participate in at least 10 hours per year averaged over three years of AMA PRA Category 1 Credit or CEC sleep-related educational activities. This must be documented for each scoring personnel member. Education sessions conducted by the SAT program are acceptable for fulfilling this standard provided the session has defined educational objective(s) and attendance is documented by a roster signed by the SAT program s medical director. B-19 Center Staff Provider Continuing Education All center staff providers, including licensed physicians, psychologists, advanced practice registered nurses and physicians assistants, must earn at least 10 credits per year averaged over three years of AMA PRA Category 1 Credit or equivalent in sleep medicine. Compliance with applicable continuing education requirements in sleep medicine must be documented. Providers who have completed a formal training program within the previous 12 months will have their credit requirements waived. Upon completion of a training program, the applicable continuing education requirement in sleep medicine will be prorated based on the end date of the program. Education sessions conducted at the facility are acceptable for fulfilling this standard provided the session has defined educational objective(s) and attendance is documented by a roster signed by the entity s medical director. B-20 SAT On-call Coverage 1. To address problems encountered in SAT, the SAT program must provide nighttime (on-call) coverage by one of the following individuals: the medical director, a licensed physician board certified in sleep medicine, or appropriately trained technical personnel addressed in standard B All calls received during testing hours must be documented in a secure log. Quarterly audits must be conducted of oncall logs to identify trends related to device, sensor or service issues. These audits must be incorporated into the SAT program s Quality Assurance Program as defined in Section J. C. Patient Policies C-1 Patient Acceptance Entities accredited by the AASM must maintain a Policy and Procedures Manual that addresses patient acceptance policies. Written policies for patient acceptance must include: Age limitations; A mechanism for acceptance; Criteria for exclusion; and Information required from a referring health-care provider prior to all sleep testing. ome Sleep Apnea tests should adhere to the criteria of high pretest probability for OSA with limited co-morbidities as described in the The specific Standard applies only to entities applying for SAT accreditation. 13

14 current versions of AASM practice parameters, AASM clinical guidelines and AASM best practice guidelines pertaining to the diagnosis of obstructive sleep apnea syndrome in adults (see Appendix A). C-2 Record Review of Direct Referrals or patients directly referred, the medical director or a designated sleep facility staff physician or the designated board certified sleep specialist must review the information provided for each patient and determine if the proposed evaluation conforms to established AASM Practice Parameters, or, if not, whether the evaluation is indicated for other reasons. Evidence of compliance with this standard must be included in the medical record. C-3 Practice Parameter Requirements The clinical evaluation of patients accepted for sleep testing must comply with applicable current versions of AASM Practice Parameters, AASM Clinical Guidelines and AASM Best Practice Guidelines. Please see Appendix A for a current list of applicable guidelines. Evidence of compliance with this standard must be included in the medical record. D. acility and Equipment D-1 Permanent Address AASM accredited entities must have a permanent, physical address recognized by the United States Postal Service; such address may not include a P.O. Box. This standard is not intended to address the issue of mail delivery, rather identification and location of the entity in which diagnostic testing is performed for facilities or provided for SAT programs. D-2 Phone Line Entities accredited by the AASM must have an independent phone line(s)/direct dial access. Phone lines/direct dial access is required for both the clinical and laboratory settings if they are separate. Entities accredited for SAT must have 24-hour telephone access to the personnel defined in Standard B-13. D-3 Signage Accredited entities must have signage on the outside of the facility or in a directory identifying the sleep entity. D-4 Stationery Entities accredited by the AASM must have professional stationery that at a minimum includes the address and phone number. or hospital-based sleep entities, this standard will be met provided the sleep entity is located in the building carrying the primary address listed on the hospital s stationery. 14 The specific Standard applies only to entities applying for SAT accreditation.

15 D-5 Use of Space Accreditation is granted to a single sleep facility, generally defined by a physical space used primarily for conducting sleep testing. All of the elements required to conduct sleep tests must be available within the defined testing space. The administrative office(s) and/or staff clinician office(s) of the sleep facility may be separate from the laboratory testing site. In such circumstances, the administrative and/or staff clinician office(s) must also meet the AASM Standards for Accreditation, as they function as a part of the broader sleep disorders facility. In circumstances of mixed use, defined as testing rooms being used for other medical testing or examination during non-sleep testing (daytime) hours, the testing room(s) must meet all of the space and equipment standards of a single use sleep testing room. D-6 Testing Bedrooms Physical Characteristics All testing bedrooms must be single occupancy, private and comfortable, have hard floor-to-ceiling walls, and a privacy door that opens directly to a corridor or common use area such that the patient can access the testing bedroom without having to pass through another testing bedroom. D-7 Testing Bedrooms & Emergency Care Patient testing bedrooms must not have any impediments to the delivery of emergency care. The patient testing rooms: 1. Must be of sufficient size to accommodate emergency personnel access with a minimum of 24 inches of available clear space on 3 sides of the bed, 2. Must include a testing bed with a mattress not smaller than a standard hospital bed. D-8 Bathroom acilities The sleep facility must have clean bathrooms with a minimum ratio of one bathroom for every three testing rooms; these bathrooms must each contain a toilet and a sink. Each bathroom must have a working privacy door. Sole access to a shared bathroom shall not be through a testing bedroom. D-9 andicap Testing Bedroom and Bathroom At least one testing bedroom and bathroom must be handicap accessible as defined either by local building regulations or sections 6.3 and 6.4 of the American with Disabilities Act (ADA) ( D-10 Control Room The dimensions of the control room must not be less than 40 square feet total or 20 square feet per testing bedroom, whichever is larger. The specific Standard applies only to entities applying for SAT accreditation. 15

16 D-11 Communication The facility must maintain a two-way communication system between the patient bedroom and the control room and/or sleep facility personnel. D-12 Video Recording Each testing bedroom in the facility must have a mechanism for visual monitoring and video recording of patients during testing. Time delayed photographs will not be considered compliant with this standard. D-13 Polygraphic Equipment The facility must maintain polygraphic equipment capable of recording and storing physiologic parameters using sensors and recommended or alternative derivations as described in the current version of The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology, and Technical Specifications. The equipment must meet all of the RECOMMENDED minimal technical and digital specifications described in section III of the manual. D-14 Portable Recording Equipment The SAT equipment must be DA approved and meet the minimum definitions described in at least one of the CPT codes 95800, or 95806: Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen saturation, and respiratory analysis (e.g., by airflow or peripheral arterial tone) Sleep study, unattended, simultaneous recording of, heart rate, oxygen saturation, respiratory airflow, and respiratory effort (e.g., thoracoabdominal movement) All reusable equipment must have a unique identifier (ID) so that it may be assigned to a patient and tracked. The ID number will be included in the patient medical record and used to assist in failure investigation and quality reporting. A process must be developed documenting that all PI and physiologic data is erased following each use of the device. Equipment used must have the capability to meet all SAT accreditation standards outlined in Sections and must be incorporated into the SAT program s Quality Assurance Program as defined in Section J. D-15 PAP Therapy The facility must maintain equipment for the delivery of positive airway pressure therapy for sleep apnea, including remote control of the device (e.g., pressure output, device mode). 16 The specific Standard applies only to entities applying for SAT accreditation.

17 E. Policies and Procedures Entities accredited by the AASM must maintain written protocols, in paper or electronic form, for all testing procedures conducted. There are additional standards in sections and I that are required to be included in the Policy and Procedures Manual. E-1 Policy and Procedures Manual Entities accredited by the AASM must maintain a Policy and Procedures Manual. The manual must contain all policies, procedures, protocols specific to the sleep entity, and all current AASM Practice Parameters, AASM Clinical Guidelines and AASM Best Practice Guidelines (see Appendix A). E-2 Protocols: PSG, SAT, MSLT, MWT, and PAP Titration All entities must maintain written, paper or electronic format, protocols. Accredited facilities must maintain protocols for comprehensive polysomnography, multiple sleep latency test, maintenance of wakefulness test, and titration of positive pressure therapy. Accredited SAT programs must maintain protocols for SAT. All accredited entities are encouraged to use Clinical Guidelines for the Manual Titration of Positive Airway Pressure in Patients with Obstructive Sleep Apnea in constructing PAP titration protocols. E-3 Other Protocols AASM accredited sleep facilities that conduct esophageal pressure monitoring, actigraphy, end tidal CO2 monitoring and transcutaneous CO2 monitoring must maintain protocols for these procedures. AASM accredited sleep facilities that test sleep patients under age 13 years must maintain population specific protocols in the Policy and Procedures Manual for comprehensive polysomnography, titration of positive pressure therapy and capnography. E-4 Equipment Maintenance A written plan for monitoring of all patient-related equipment for electrical and mechanical safety is required. The written plan must include specific instructions regarding documentation of compliance. E-5 acility Equipment Maintenance The plan must address monthly visual inspection of equipment by staff for apparent defects; adhering to manufacturer s recommendations for monitoring and maintenance of recording equipment; and annual electrical safety testing by a certified electrician or biomedical engineer. The specific Standard applies only to entities applying for SAT accreditation. 17

18 E-6 SAT Equipment Maintenance The written SAT equipment maintenance plan required by Standard E-4 must include an equipment maintenance log. The plan must address: visual inspection of equipment for apparent defects; adhering to manufacturer s recommendations for monitoring and maintenance of recording equipment. In addition the SAT program must meet the following requirements related to equipment maintenance: 1. The SAT program must have a written procedure for infection control including cleaning and inspecting equipment and the application of germicidal agents after each use that is consistent with the germicidal manufacturers recommendations, federal and state health policy regulations and institutional standards. 2. Specific instructions must exist for device and sensor packing, shipping and storage. An area must be designated for clean versus dirty devices. 3. All devices and sensors associated with a failed test (i.e. no data, inadequate data, or corrupt data) must be removed from service and tested for proper function prior to its next use. 4. Reported or detected failures of devices, sensors or processes must be categorized and analyzed for cause (This must be incorporated into the SAT program s Quality Assurance Program as defined in Section J).. Data Acquisition, Scoring and Reporting -1 Signals and Equipment The signals collected and the equipment used for comprehensive polysomnography must be in compliance with the current version of The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology, and Technical Specifications. -2 PSG Reports Reports of polysomnography must include all the RECOMMENDED and ACCEPTED parameters from section II of the current version of The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology, and Technical Specifications. -3 SAT Recording Equipment Accredited SAT programs must use DA approved equipment that provides a measure of respiratory events per unit time (REI). The Medical Director must determine that the device provides a measure that is equivalent to an apnea-hypopnea index (AI) based on full polysomnography. Equipment must also measure oxygen saturation and heart rate and meet the criteria for the codes designated in standard D-14. Equipment must allow for the display of raw data for manual scoring or editing. 18 The specific Standard applies only to entities applying for SAT accreditation.

19 -4 SAT Reports and Interpretations The data included in SAT reports must include at minimum: Type of Device Used Date of testing Duration of test recording Respiratory Event Index (REI) and total number of respiratory events A summary of oxygen desaturations (which may be ODI, % of time below certain thresholds, mean, minimum and/or maximum O2 saturations) during recording period eart rate during the recording period Technical adequacy of test Interpretation (based upon test results and clinical information), including at a minimum whether the test results support a diagnosis of obstructive sleep apnea or not Signature (electronic or ink) of interpreting sleep physician Any recommendations for next management steps (based upon test results and clinical information), if provided, must be consistent with applicable AASM Standards of Practice, AASM Practice Guidelines, and AASM Best Practice papers. -5 Conducting MSLT and MWT The multiple sleep latency test and maintenance of wakefulness test must be conducted using the protocol described in Box 1 and Box 2 of the Standards of Practice Committee of the American Academy of Sleep Medicine: Practice Parameters for Clinical Use of the Multiple Sleep Latency Test and the Maintenance of Wakefulness Test. -6 PSG Scoring Each epoch of each polysomnogram must be scored for sleep staging, arousals, respiratory events and limb movement in accordance with The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology, and Technical Specifications. -7 Computer-assisted Scoring If used, computer-assisted scoring of polysomnography must be reviewed and edited for accuracy. The specific Standard applies only to entities applying for SAT accreditation. 19

20 -8 Inter-scorer Reliability Inter-scorer reliability (ISR) must be determined between each scorer and a reference sleep specialist as defined in standard B-7 or a corporate appointed board certified sleep specialist; such individual must be an employee of the corporation and serves as the reference sleep specialist. ISR assessment must be conducted for each sleep facility. In cases where a corporate sleep specialist serves as the reference standard for inter-scorer reliability, the sleep facility s designated board certified sleep specialist must attest in writing that he/she has reviewed the results of the inter-scorer reliability assessment and will take corrective action when results fall below the sleep facility s level of acceptable agreement as defined in its quality assurance program. or comprehensive polysomnography, the following parameters must be compared: sleep staging epoch-by-epoch agreement, respiratory events, leg movements and arousals. Sleep technologists must be blinded to the scoring of the sleep facility designated reference specialist and to all other scoring technicians. Comparisons between each scorer and the facility s designated reference sleep specialist must be made on 200 consecutive 30-second epochs in each of three polysomnograms per quarter, for a total of 12 polysomnograms per year. Comprehensive polysomnography studies must report agreement between scorer and the facility s designated reference sleep specialist as percent concordance defined as the quotient of the total number of epochs of agreement for a given parameter and the total number of epochs in the analysis sample multiplied by 100. Sleep related breathing event comparisons for laboratory polysomnography must at minimum include analysis by total number of events and by the following event types: Obstructive apnea, central apnea and hypopnea. If the sleep facility reports respiratory effort related arousals, this event must be included in the comparison. Use of the AASM Inter-Scorer Reliability program fulfills the requirements of this standard. -9 Review of Raw Data Any individual meeting the requirements in Standard B-7 can interpret a polysomnogram, multiple sleep latency test or maintenance of wakefulness test and must conduct an epoch-by-epoch review of the entire raw data recording for every study interpreted. The review of the data must assure that the quality of the recording and the scoring of sleep and associated events is sufficient to allow for interpretation. Signed attestation of this review must be kept either in the patient record in the form of signature on the report of the test or in a separate journal. Any individual that meets the requirements in Standard B-7 can over-read the raw data and interpretations of staff physicians who do not meet requirements in Standard B-7. Signed attestation of this review must be kept either in the patient record in the form of signature on the report of the test or in a separate journal. -10 Review of SAT Raw Data Any physician meeting the requirements in Standards B-10, B-11, and B-12 can interpret an SAT and must conduct an epoch-by-epoch review of the entire raw data recording for every SAT study interpreted. The review of the data must assure that the quality of the recording and the scoring of sleep and associated events is sufficient to allow for interpretation. Signed attestation of this review must be kept either in the patient record in the form of signature on the report of the test or in a separate journal. 20 The specific Standard applies only to entities applying for SAT accreditation.

21 G. Patient Evaluation and Care G-1 Patient Management (MANDATORY) In accordance with the entity s patient acceptance policies, its physicians must demonstrate the capability and experience diagnosing and managing the full range of sleep disorders. The program must have charts and records available to demonstrate the diagnosis and management of the full range of sleep disorders. This includes availability (within the entity or by referral) of recognized and effective treatments for these disorders. Appropriate follow-up for patients who require continued management must be offered and available. G-2 Patient Management Continued (MANDATORY) Appropriate follow-up must be available from the SAT program or by referral. A record of any patient management must be included in the patient s medical record. If continued management requires a full diagnostic sleep test in a laboratory, the SAT program must demonstrate, in writing, an existing relationship with an accessible AASM accredited sleep facility that can provide this care, and the SAT program must supply the referring physician with contact information regarding the local AASM accredited facility in their network. G-3 Documenting Patient Evaluation/Management Entities accredited by the AASM must document ongoing evaluation and management of patients with sleep disorders. The documentation must be included as part of the patient s medical record. or entities that offer SAT, technical failures due to equipment malfunction must be documented and the study repeated. acility polysomnography must be recommended in cases where adequately performed SAT does not establish the diagnosis of OSA in patients with a high pre-test probability. If facility testing is not provided by the SAT program, the SAT program must provide written documentation (such as a letter of understanding that both parties have signed) of a relationship with an AASM accredited sleep facility.. Patient Records -1 Medical Records All entities accredited by the AASM must maintain appropriate medical records for each patient evaluated by the sleep facility medical staff and for directly referred patients. Medical records of patients seen by medical staff must document all patient interactions, including initial evaluation, testing (if any), diagnosis, treatment, PAP assessment and follow-up. Prior to testing, all patient medical records must include: history and physical examination or patient questionnaires, or other screening assessment. The record must include written indication that either a physician or the designated sleep specialist has reviewed and approved the proposed evaluation for both facility and SAT testing. The specific Standard applies only to entities applying for SAT accreditation. 21